Streptococcus Group ANCT00436891
Streptococcal Infections in Fiji - Prevalence of Group A Streptococcal Pyoderma and Scabies in Infants in Fiji
An observational study of Streptococcus Group A, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Fiji.
Trial summary
Group A streptococcus (GAS) is a bacteria that causes many different sicknesses in children and adults. This study will look at the number of cases of pyoderma (bacterial skin infection) and scabies (skin mites that cause itching) in 550 infants 12 months or younger in Fiji. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Group A
- How many people
- 550 participants
- Where
- 1 siteFiji
- Study dates
- Feb 2007to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent from parents/guardians will be obtained for all study participants.
- Infants less than or equal to 12 months of age
- Attending Navua Health Center and/or Raiwaqa/Vatuwaqa Health Centre
- Infants can only be enrolled on one occasion.
Who cannot join
- 1. Subjects greater than 12 months of age
Trial locations and contacts
1 site in 1 country.
Fiji1 site
Colonial War Memorial Hospital
Suva
About this study
Official title: The Epidemiology of Group A Streptococcal Infections in Fiji (Fiji GrASP) - Part 4 -The Prevalence of Group A Streptococcal Pyoderma and Scabies in Infants in Fiji
Group A streptococcus (GAS) is a bacteria that causes many different sicknesses in children and adults. This study will look at the number of cases of pyoderma (bacterial skin infection) and scabies (skin mites that cause itching) in 550 infants 12 months or younger in Fiji. (GAS can cause pyoderma, and sometimes skin sites infested with scabies can become infected with GAS bacteria.) The study will also look at the makeup of GAS and how certain medications affect GAS. The infants will be involved in the study for approximately 1 week. Their skin will be examined for pyoderma and scabies. A swab sample will be taken from the pyoderma area to test for GAS. The researchers hope to see how often these skin infections occur and how they affect the Fijian population. The information will help the researchers to develop better treatment and possibly a vaccine to prevent infection. Infants with pyoderma that is defined as "greater than mild" will be referred for treatment.
Read the detailed description
Group A beta-hemolytic streptococcus, a common infective agent in children and adults, causes the widest range of clinical disease of any bacterium. This study is the fourth of five studies in a larger project aimed at evaluating the epidemiology of infections caused by the group A streptococcus (GAS) in Fiji. This larger project is called the Fiji Group A Streptococcal Project (Fiji GrASP). Fiji GrASP is in turn part of a larger program aimed at progression of a novel GAS vaccine - this program is the project entitled "Global GAS Vaccine Based on the M-Protein." The three broad aims of the Fiji GrASP epidemiologic studies are: (1) to establish the burden of disease of GAS infections in Fiji; (2) to describe the molecular epidemiology of GAS isolates in Fiji and; (3) to establish natural immunologic correlates of protection of a J8 vaccine if they exist. This is a cross-sectional study of 550 infants over a 2-month period. Skin will be examined for pyoderma and scabies, and swabs will be taken from pyoderma lesions once. All GAS isolates from skin swabs will undergo genetic sequencing of the N-terminal and C-repeat regions (for the J8 epitope) of the M protein at QIMR. One hundred skin swabs will undergo antimicrobial susceptibility testing against penicillin, erythromycin, clindamycin and chloramphenicol. The primary objectives of the study are to estimate the point prevalence of GAS pyoderma in 550 infants in the Central Division of Fiji and to estimate the point prevalence of scabies in 550 infants in the Central Division of Fiji. The secondary objectives of the study are to genotypically characterize group A streptococci isolated from skin swabs from pyoderma lesions in infants in Fiji and to determine antimicrobial susceptibility to penicillin, clindamycin, erythromycin and chloramphenicol in 100 GAS isolates from skin swabs. The primary endpoints of the study are to determine the number of cases of pyoderma and the number of cases of scabies. The secondary endpoints are: (1) to determine the number of children with pyoderma and scabies; (2) to determine the number of GAS isolates from skin swabs that contain the J8 epitope and the overall emm-type distribution of GAS isolates and; (3) to complete antibiograms of GAS isolates from skin to penicillin, clindamycin, erythromycin and chloramphenicol.
- Conditions
- Streptococcus Group A
- Keywords
- Group A Streptococcus, scabies, pyoderma, Fiji
- Medical subject headings
- Scabies, Pyoderma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Group AStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 550 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436891
- Sponsor's protocol ID
- 06-0081
- Other IDs
- Fiji GrASP Part 4
- Status last verified
- Oct 2007
- First submitted
- 16 Feb 2007
- Last updated
- 2 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology of Group A Streptococcal Infections in Fiji (Fiji GrASP) - Part 4 -The Prevalence of Group A Streptococcal Pyoderma and Scabies in Infants in Fiji
- ClinicalTrials.gov ID
- NCT00436891
- Acronym / sponsor ID
- 06-0081
- Conditions
- Streptococcus Group A
- Keywords
- Group A Streptococcus, scabies, pyoderma, Fiji
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2007
- Study completion
- Apr 2007
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Group A streptococcus (GAS) is a bacteria that causes many different sicknesses in children and adults. This study will look at the number of cases of pyoderma (bacterial skin infection) and scabies (skin mites that cause itching) in 550 infants 12 months or younger in Fiji. (GAS can cause pyoderma, and sometimes skin sites infested with scabies can become infected with GAS bacteria.) The study will also look at the makeup of GAS and how certain medications affect GAS. The infants will be involved in the study for approximately 1 week. Their skin will be examined for pyoderma and scabies. A swab sample will be taken from the pyoderma area to test for GAS. The researchers hope to see how often these skin infections occur and how they affect the Fijian population. The information will help the researchers to develop better treatment and possibly a vaccine to prevent infection. Infants with pyoderma that is defined as "greater than mild" will be referred for treatment.
Detailed description
Group A beta-hemolytic streptococcus, a common infective agent in children and adults, causes the widest range of clinical disease of any bacterium. This study is the fourth of five studies in a larger project aimed at evaluating the epidemiology of infections caused by the group A streptococcus (GAS) in Fiji. This larger project is called the Fiji Group A Streptococcal Project (Fiji GrASP). Fiji GrASP is in turn part of a larger program aimed at progression of a novel GAS vaccine - this program is the project entitled "Global GAS Vaccine Based on the M-Protein." The three broad aims of the Fiji GrASP epidemiologic studies are: (1) to establish the burden of disease of GAS infections in Fiji; (2) to describe the molecular epidemiology of GAS isolates in Fiji and; (3) to establish natural immunologic correlates of protection of a J8 vaccine if they exist. This is a cross-sectional study of 550 infants over a 2-month period. Skin will be examined for pyoderma and scabies, and swabs will be taken from pyoderma lesions once. All GAS isolates from skin swabs will undergo genetic sequencing of the N-terminal and C-repeat regions (for the J8 epitope) of the M protein at QIMR. One hundred skin swabs will undergo antimicrobial susceptibility testing against penicillin, erythromycin, clindamycin and chloramphenicol. The primary objectives of the study are to estimate the point prevalence of GAS pyoderma in 550 infants in the Central Division of Fiji and to estimate the point prevalence of scabies in 550 infants in the Central Division of Fiji. The secondary objectives of the study are to genotypically characterize group A streptococci isolated from skin swabs from pyoderma lesions in infants in Fiji and to determine antimicrobial susceptibility to penicillin, clindamycin, erythromycin and chloramphenicol in 100 GAS isolates from skin swabs. The primary endpoints of the study are to determine the number of cases of pyoderma and the number of cases of scabies. The secondary endpoints are: (1) to determine the number of children with pyoderma and scabies; (2) to determine the number of GAS isolates from skin swabs that contain the J8 epitope and the overall emm-type distribution of GAS isolates and; (3) to complete antibiograms of GAS isolates from skin to penicillin, clindamycin, erythromycin and chloramphenicol.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Informed consent from parents/guardians will be obtained for all study participants.
- Infants less than or equal to 12 months of age
- Attending Navua Health Center and/or Raiwaqa/Vatuwaqa Health Centre
- Infants can only be enrolled on one occasion.
Key exclusion criteria (1 listed)
- 1. Subjects greater than 12 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Group A, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Fiji.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Fiji. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2008.